Testosterone decline in men has been well studied in the prior art and is associated with decline in both physical and mental function.
Symptoms of androgen/testosterone deficiency include: reduced libido, hot flushes and sweating, breast development, lethargy and fatigue, depression, reduced muscle mass and strength, increased body fat—particularly around the abdomen and reduced bone mass, loss of body hair, increase in blood low density lipoproteins together with a decrease in high density lipoproteins
The most reported symptoms of androgen deficiency are lack of energy, lack of motivation, and reduced libido.
Testosterone replacement has been successfully employed to try and reverse symptoms of androgen/testosterone deficiency.
FDA approved products for testosterone replacement include: topical gels, patches, intramuscular injections of testosterone esters and subcutaneous pellets.
Oral preparations of synthetic androgens have also been used in the prior art but have been associated with significant side effects. Consequently, their usefulness has been very limited.
It is known in the art that free unesterified testosterone is readily absorbed from the gut but is inactivated by the liver before the testosterone reaches the target organs. Only extremely high doses (e.g. 200 mg) have been shown to be measurable in serum.
Testosterone USP is not effective when taken orally by patients in need of such therapy. Consequently, testosterone is generally administered by injection.
Since oral dosage forms are easier to take and use of same affords greater patient compliance, there is a great need in the medical arts for an oral dosage form of testosterone USP which when orally administered provides therapeutically effective blood levels of testosterone.